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Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-label, Phase 2 Trial.

Efficacy of Sofosbuvir, Velpatasvir, and GS-9857 in Patients With Hepatitis C Virus Genotype 2, 3, 4, or 6 Infections in an Open-label, Phase 2 Trial. Gastroenterology Gane, E., Kowdley, K. V., Pound, D., Stedman, C. A., Davis, M., Etzkorn, K., Gordon, S. C., Bernstein, D., Everson, G., Rodriguez-Torres, M., Tsai, N., Khalid, O., Yang, J. C., Lu, S., Dvory-Sobol, H., Stamm, L. M., Brainard, D. M., McHutchison, J. G., Tong, M., Chung, R. T., Beavers, K., Poulos, J. E., Kwo, P. Y., Nguyen, M. H. 2016

Abstract

Studies are needed to determine the optimal regimen for patients with chronic hepatitis C virus (HCV) genotype 2, 3, 4, or 6 infections who have failed by a prior course of antiviral therapy, and the feasibility of further shortening treatment duration. We performed a phase 2 study to determine the efficacy and safety of the combination of the nucleotide polymerase inhibitor sofosbuvir, the NS5A inhibitor velpatasvir, and the NS3/4A protease inhibitor GS-9857 in these patients.We performed a multicenter, open-label trial at 32 sites in the United States and 2 sites in New Zealand, from March 3, 2015 to April 27, 2015. Our study included 128 treatment-naïve and treatment-experienced patients (1 with HCV genotype 1b, 33 with HCV genotype 2, 74 with HCV genotype 3, 17 with genotype HCV 4, and 3 with HCV genotype 6), with or without compensated cirrhosis. All patients received sofosbuvir-velpatasvir (400 mg/100 mg fixed-dose combination tablet) and GS-9857 (100 mg) once daily for 6-12 weeks. The primary endpoint was sustained virologic response 12 weeks after treatment (SVR12).Following 6 weeks of treatment, SVR12s were achieved by 88% of treatment-naïve patients without cirrhosis (29/33; 95% CI, 72%-97%). Following 8 weeks of treatment, SVR12s were achieved by 93% of treatment-naïve patients with cirrhosis (28/30; 95% CI, 78%-99%). After 12 weeks of treatment, SVR12s were achieved by all treatment-experienced patients without cirrhosis (36/36; 95% CI, 90%-100%) and 97% of treatment-experienced patients with cirrhosis (28/29; 95% CI, 82%-100%). The most common adverse events were headache, diarrhea, fatigue, and nausea. Three patients (1%) discontinued treatment due to adverse events.In a phase 2 open-label trial, we found sofosbuvir-velpatasvir plus GS-9857 (8 weeks in treatment-naïve patients or 12 weeks in treatment-experienced patients) to be safe and effective for patients with HCV genotype 2, 3, 4, or 6 infections, with or without compensated cirrhosis. ClinicalTrials.gov no: NCT02378961.

View details for DOI 10.1053/j.gastro.2016.07.038

View details for PubMedID 27486033